Food and Drug Administration
FDA
MANDATES
PRESENTATION
[Link]
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
Presentation Outline:
INTRODUCTION
FDA’s Legal Mandates, Vision, Mission, and Organogram.
REGULATORY ACTIONS
Handling of Complaints and Enforcement Activities.
ACCOMPLISHMENTS
REU’s Accomplishments for 2022 and 2023.
INTRODUCTION
The Food and Drug Administration (FDA) is
mandated by the Republic Act No. 9711: “FDA
Act of 2009,” to ensure the safety, efficacy,
and quality of the following health products:
➢ Food
➢ Drugs/ Biologicals/ Vaccines
➢ Cosmetics
➢ Medical Devices
➢ Household/ Urban Hazardous
Substances including Pesticides
and Toys
Vision And Mission
To guarantee the safety,
To be an internationally quality, purity, efficacy of
recognized center of health products in order
excellence in health to protect and promote
product regulation by the right to health of the
2026. general public.
FDA Organogram
ACCOMPLISHMENTS
Office of the Director
General
(Summary)
INSERT TEXT
DR. SAMUEL A. ZACATE
(FDA Director General)
Office of the Deputy
Office of the Deputy
Director General for - Center for Drug Regulation and Research
Director General for
Field Regulatory
Internal - Center for Food Regulation and Research
Operation Office
Management (IM) - Center for Device Regulation, Radiation
(FROO)
Health and Research
- Center for Cosmetics and Household/Urban
Hazardous Substances Regulation and
5 Clusters (North Research
Administrative and and South Luzon, Regulatory
- Common Services Laboratory (CSL)
Finance Services Visayas, Mindanao Enforcement Unit
(AFS) East, and Mindanao (REU) - Policy and Planning Service (PPS)
West) - Legal Services Support Center (LSSC)
Complete FDA Organogram: [Link]
STATE POLICIES
R.A. 8203: Special Law on Counterfeit Drugs
Section 3(b) defined Counterfeit Drugs/ Medicines as medicinal
products with:
✓ “With correct ingredients but NOT in the amounts provided;
✓ Wrong Ingredients;
✓ Without Active Ingredients;
✓ With insufficient quantity of active ingredient/s;
✓ Mislabeled and fraudulent packaging.
Commonly Counterfeited Medicines
• Popular medicines with high demand
–Over the counter Cough and Cold Medicines
–Leading branded-generic medicines in the market
–Antibiotics, Antihypertensives
• Lifestyle medicines
–products for erectile dysfunction
–slimming products
• Rabies vaccines
Local Incidence of Counterfeit Medicines
No. of Counterfeit Drugs
(January-November 2023)
Prescription 8
Home Remedy 4
Over-The-Counter 19
TOTAL: 31 Counterfeit Drugs
Presentation Outline:
INTRODUCTION
FDA’s Legal Mandates, Vision, Mission, and Organogram.
REGULATORY ACTIONS
Handling of Complaints and Enforcement Activities.
ACCOMPLISHMENTS
REU’s Accomplishments for 2022 and 2023.
INITIATIVES TOWARDS PREVENTION
Partnership with the academe, stakeholders,
LGUs, and Law Enforcement Agencies
INITIATIVES TOWARDS PREVENTION
Collaboration with Bureau of Customs (BoC)
for Border Control Measure to prevent entry in
the country of prohibited and violative health
products.
INITIATIVES TOWARDS PREVENTION
Market Monitoring and
Surveillance including that of
the social media and online
selling platforms
All violative or prohibited
listings/posts are coordinated
to the platform through
warning letters
INITIATIVES TOWARDS PREVENTION
Conduct of Advocacy Activities and Information
drives.
Participation to the National Consciousness Week
Against Counterfeit Medicines [Presidential
Proclamation No. 2082 s. 2010]
INITIATIVES TOWARDS DETECTION
INITIATIVES TOWARDS DETECTION
INITIATIVES TOWARDS RESPONSE
Issuance of FDA Advisories and Orders.
WAYS TO REPORT
Handling of Complaints
Customer
Complaints
COMPLAINANT
E-REPORT SECTION
(FDAC)
1) Concerned CENTER
CONCERNED CENTER
2) Field Regulatory Operation
[FDA Circular No. 2013-022: / OFFICE
Office (FROO)
Guidelines on Handling
Consumer Complaints]
Handling of Complaints
MAH / Brand Owner Affidavit of Complaint
1) The name, lot numbers, and expiry date of the suspected
product;
2) The source or the name and address of the person from
whom he/she acquired the said suspected drug product;
[IRR of R.A. 8203] 3) The mode of his acquisition, and
RULE IV: Procedure
4) The reason or fact giving rise to the suspicion that the drug
in the Filing of
product is counterfeit.
Administrative
Complaint
Consumer or Prescriber (Letter Content)
(Section 1)
1) The name of the suspected product;
2) The source or the name and address of the person from
whom he/she acquired the said suspected drug product;
3) The mode of his acquisition, and
4) The reason or fact giving rise to the suspicion that the drug
product is counterfeit.
Handling of Complaints
Procedure when Information is received by FROO:
If establishment is LICENSED: If establishment is not covered
Segregate, inventory, and seal by valid LTO:
Search Warrant Search Warrant
VERIFY/INVESTIGATE THE CASE Product inventory and Seizure
Product Seizure
Filing of Filing of
Criminal/Administrative Criminal/Administrative
Complaint Complaint
Handling of Complaints
RESPONSE
Filling of Report of
Violation to Legal
Issuance of FDA
Services Support Center
Advisories for appropriate Legal
Action
Collection and Seizure:
Entrapment/ Buy-Bust Operation
Investigation, Test Buy, Product Verification,
Referral/Co Case Build-
Case Conference/Coordination and
mplaint up
Preparation of Documentary Requirements
Actual Entrapment/ Buy Bust Operation:
-Poseur buyer with marked money
Court Duty
-Inventory, Collection and Seizure of Counterfeit Medicines
- Arrest the Suspect (In coordination with other LEA’s)
Collection and Seizure:
REU Actual: Entrapment/Buy-Bust Operation
Collection and Seizure:
Implementation of Search Warrant
Investigation, Test Buy, Product Verification,
Referral/Co Case Build-
Case Conference/Coordination and
mplaint up
Preparation of Documentary Requirements
Actual Operation of SW: (w/in 10 days upon issuance of court)
-Coordination to LGU’s
Court Duty
-Inventory, Collection and Seizure of Counterfeit Medicines
Return of SW (w/in 10 days upon implementation
Collection and Seizure:
REU Implementation of Seizure/FDA Order
FDA Advisories with FDA Order
Investigation, Collection of Samples, Test buy for Product
Verification and Preparation of Documentary Requirements
Planning, Case Conference, Coordination, and
Implementation of FDA Order
REU Seizing officer shall turn over the collected violative
health products to the Evidence custodian.
Submission of Activity Report
FDA Initiatives & Projects
FDA OPLAN KATHAROS
➢ Develops and implements guidelines relative to the proper handling, storage, and disposal
of seized health products.
➢ Heightens security and safe keeping, including proper disposal of seized counterfeit drug
products and other health products.
➢ Strengthens collaboration with law enforcement agencies in order to substantially reduce ,
if not totally eliminate the unauthorized health products in the market and the related
illegal sale and distribution activities thereof.
BORDER CONTROL
➢ Collaborates with the Bureau of Customs (BoC) and other government agencies in
preventing the entry of unregistered and/or counterfeit health products in the country.
DIGITALIZATION
➢ Promotes the use of an FDA Verification Portal in identifying registered health products.
[[Link]
➢ Raising awareness through the continuous posting of FDA advisories to different social
media platforms.
Presentation Outline:
INTRODUCTION
FDA’s Legal Mandates, Vision, Mission, and Organogram.
REGULATORY ACTIONS
Handling of Complaints and Enforcement Activities.
ACCOMPLISHMENTS
REU’s Accomplishments for 2022 and 2023.
Accomplishments
FDA Data on Counterfeit Drugs for CY 2022
Date of Place of Operation Product/s Seized Type of Operation Other LEA Estimated Cost
Operation
05 January Quezon City Various Over-the- Implementation of BoC (CIIS-MICP) 10,000,000.00
Counter (OTC) Drugs Letter of Authority
17 January Various OTC Drugs Buy-bust PNP (NPD-DSOU) 109,000.00
operation
26 January Legaspi City, Albay Bioflu and Biogesic Buy-bust NBI (BRO Legaspi 1,000.00
operation City)
15 February Bislig City, Surigao Various OTC Drugs Buy-bust PNP (Bislig City Police 13,282.50
del Sur operation Station)
18 February Cagayan De Oro Various OTC Drugs Buy-bust PNP (Station 2 43,666.00
City operation Cagayan De Oro City
Headquarters
05 March Ozamis City, Various OTC Drugs Service of Search PNP (RSOU-10) 3,500,000.00
Misamis Oriental Warrant
07 March Tanza, Cavite Various OTC Drugs Buy-bust PNP (CIDG-Cavite) 2,310.00
operation
TOTAL: 13,669,259.00
Accomplishments
FDA Data on Counterfeit Drugs for CY 2023
Date of Place of Operation Product/s Seized Type of Operation Other LEA Estimated Cost
Operation
Mandaue and Buy Bust Operation NBI Cebu
May Mindenilla NORIFAMDK KIT 53,000.00
Various Over-the- Implementation of Local Government Unit,
Sitio Bombong, Salong, Counter Drugs FDA Order Brgy. Salong, Calapan 3,626.00
Calapan City Oriental (Paracetamol, Biogesic, City, Oriental Mindoro
23 May Mindoro Alaxan FR, Bioflu)
OTC Linhua Qingwen Implementation of N/A
Cabatuan, Isabela Jianaong (Chinese Legal Order 36,750.00
18 May (Region 2) Character)
Implementation of Rep and local officials of
San Vicente, Palawan OTC Drugs Legal Order San Vicente, Palawan
and San Miguel, Puerto and San Miguel, Puerto
June Princesa, Palawan Princesa, Palawan 5,850.00
Osmena St., Zone 2, Aspen Xylocaine Pump Inspection N/A
10 August Sogod, Southern Leyte Spray 8,008.00
Verorab and Vaxirab Implementation of N/A
August Davao Del Norte (Vial Drug) FDA Order 19,605.00
Vaxirab N and Equirab Implementation of N/A
28 September Cagayan De Oro (Vial Drug) FDA Order 1,456,892.50
TOTAL: 1,583,731.50
MAJOR Accomplishments (2023)
FDA REU RFO III joint operation with the Bureau
of Customs (BoC), Sugar Regulatory
Administration (SRA), Philippine Drug
Enforcement Agency (PDEA), Bureau of Fishery
and Aquatic Resource (BFAR), Philippine Coast
Guard (PCG) and Subic Bay Management
Authority (SBMA) at the SBITC, Olongapo City,
Zambales. [23 March 2023]
During the Inspection:
- Various misdeclared assorted frozen meats
and refined sugar were found and seen
upon opening of the containers.
- Issued a Warrant of Seizure and Detention
(WSD) against the subject containers for
violation of Section 1400, in relation to
Section 1113 (f) of the Republic Act 10863 or
the Customs Modernization and Tariff Act
(CMTA), and Sugar Regulatory Authority
and BOC Joint Memorandum Order No. 04-
2002.
MAJOR Accomplishments (2023)
FDA Operations thru serving of legal orders in different areas of Metro Manila.
ONLINE MONITORING
ONLINE PLATFORM 2022 2023
SHOPEE 147 313
LAZADA 101 258
FACEBOOK 168 239
OTHERS 53 16
TOTAL 469 826
OVERALL TOTAL: 1,295
Challenge:
➢ Proliferation of Online Sale of Violative Health Products
➢ Continuous posting by online sellers [different account] even after the violative
product was taken down.
Food and Drug Administration
THANK YOU
FOR YOUR ATTENTION
[Link]
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
